This invention relates to a biocompatible, biostable and implantable heart sack which is prepared from biocompatible, biostable and implantable elastomers selected from the group consisting of polyetherurethane, polycarbonateurethane, silicone, poly(siloxane) urethane and/or hydrogenated poly (styrene-butadiene) copolymer for the treatment of cardiomyopathy, hypertrophic cardiomyopathy, tachycardia, bradycardia, ventricular fibrillation, atrial fibrillation etc. The heart sack of this invention can be reinforced with mono-filaments, yarns, braids, cords, knitted or woven or non-woven cloth made of a biocompatible, biostable, implantable polyamide, polyimide, polyester, polypropylene, and/or polyurethane etc.
The heart sack of this invention can be equipped with pacemaker leads and defibrillation leads. The leads and electrodes of this invention are made of noble metal or stainless steel deposited, coated or plated mono-filaments, yarns, braids, cords, wires, films, cloth and/or cylindrical tubes. The noble metal used for this invention is selected from the group consisting of gold, platinum, rhodium and their alloys. The mono-filaments, yarns, braids, cords, wires, films, cloth or cylindrical tubes materials to be coated, deposited or plated with noble metal are selected from the group consisting of poly(ethylene terephthalate), poly(butylene terephthalate), polyamide, polyimide, polypropylene, polyetherurethane, polycarbonateurethane and their copolymers. The heart sack and electrodes are very flexible and have good biocompliance with heart muscle. They have high strength and excellent mechanical properties. Ordinary pacemaker leads and defibrillation leads could be also imbedded into the heart sack to provide cardiac pacing or defibrillation.
Electrical therapeutic heart sack devices are a new and noble concept. Cardiomyopathy is a commonly observed disease in an aging population. Cardiomyopathy is a defect of myocardial function. There are three categories of Cardiomyopathies; dilated cardiomyopathy, hypertrophic cardiomyopathy and restrictive cardiomyopathy. Dilated cardiomyopathy refers to a condition in which there is weakened contraction of the ventricles with an apparent dilation of the ventricles. This leads to inadequate perfusion, and increased pulmonary and systemic venous congestion. It will lead essentially to loss of heart function. The history of the disease is one of progressive deterioration. The mortality in one year is greater than 50% for those people who have a poorly functioning heart. Hyper cardiomyopathy is a disease of the heart muscle. It is characterized with an overactive left ventricle due to its increase in muscle mass resulting in an obstruction of the blood that is being pumped from the left ventricle to the rest of the body. This causes dyspnea on exertion and chest pain due to ischemia. Currently, there is no treatment to alter the course of the disease. Restrictive cardiomyopathy is least common of cardiomyopathies. It is due to other pathological processes such as scerderma, amyloid, sarcoid, or storage decease. This invention is to prevent enlargement of the heart and thinning of the heart wall of patients with dilated cardiomyopathy, or hypertrophic cardiomyopathy by the use of a heart sack.
The implantable heart sack of this invention was prepared from a biocompatible, biostable and implantable elastomer selected from the group consisting of polyetherurethane, polycarbonateurethane, silicone, polysiloxaneurethane and/or hydrogenated poly (styrene-butadiene) copolymer. Grooves can be made on the inside of the sack to accommodate blood vessels and pacing or defibrillation leads. Holes can be punched out from the heart sack to accommodate the pulmonary artery and aorta. The heart sack can be made to be a semipermeable membrane by providing numerous micro holes in the heart sack. This can be done mechanically, or by phase inversion casting method, or leaching out a soluble blend from an injection molded heart sack. Many larger holes can be perforated in the heart sack to allow body fluid to freely flow around the heart sack. The heart sack of this invention can be reinforced with mono-filaments, yarns, braids, cords, knitted, woven and/or non-woven cloth made of a biostable, implantable polyamide, polyimide, polyester, polypropylene, or polyurethane etc. The heart sack is split from the upper edge of the sack through the pulmonary artery and aorta openings. In this way, the sack can be opened to fit onto the heart. Several sutures are attached on one side or both sides of the cutting. Suturing makes the heart sack fit tightly onto the heart. Ordinary pacemaker leads and defibrillation leads can be imbedded into the heart sack to treat tachycardia, bradycardia, ventricular fibrillation, atrial fibrillation etc. However, the ordinary pacemaker leads that interface with the exterior of the heart often lack physical and physiological compliance with the heart muscle and its surrounding tissue resulting in mechanical abrasion and scar formation. To prevent abrasion, the pacemaker leads and/or electrode of this invention are made of noble metal or stainless steel coated, deposited or plated mono-filaments, yarns, braids, cords, wires, films, cloth cylindrical tubes, and laminated films. These articles are encased in multi-lumen insulating tubing having at least two lumens or in layers of the coaxial insulation tubes.